REGU08001 2017 Introduction to Quality Management Systems

General Details

Full Title
Introduction to Quality Management Systems
Transcript Title
Quality Mgmt Systems
Code
REGU08001
Attendance
N/A %
Subject Area
REGU - Regulatory Affairs
Department
LIFE - Life Sciences
Level
08 - NFQ Level 8
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2017 - Full Academic Year 2017-18
End Term
9999 - The End of Time
Author(s)
Mary Butler, Ailish Breen
Programme Membership
SG_SMEDI_L08 201900 Higher Diploma in Science in Science in Medical Device Regulatory Affairs and Quality SG_SMEDI_E08 201900 Certificate in Science in Medical Device Regulatory Affairs and Quality
Description

This module aims to provide students with an introduction to and understanding of setting up a basic QMS and its implementation. It also aims to provide the students with an understanding of the requirement for a quality management system and how to design this quality system under the CFR 820 or ISO13485 headings.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Describe the evolution of Quality Management Systems

2.

Describe a basic QMS and its components

3.

Explain the application and requirements of a QMS as prescribed by 21CFR 820

4.

Explain the application and requirements of a QMS as prescribed by ISO13485:2016

5.

Describe the quality tools necessary to implement and achieve continuous quality improvement in the manufacturing

6.

Illustrate the audit requirements of a QMS and how to deal with auditors.

7.

Understand how to apply ethics and scientific integrity to professional practice.

Teaching and Learning Strategies

Content will be delivered primarily via online and blended methods. Additional lecturing, as required, may be provided by outside specialists and practitioners. Learning strategies including evidence based and enquiry based learning also will be used.  Resources used will include Moodle, Adobe connect, Panopto, and other multimedia such as youtube, webinars, literature databases.

Module Assessment Strategies

The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ's, project assignments, group reports and essays and oral presentations.

Repeat Assessments

Repeat assignments will be given.

Indicative Syllabus

This module aims to provide students with an introduction to and understanding of setting up a basic QMS and its implementation. It also aims to provide the students with an understanding of the requirement for a quality management system and how to design this quality system under the CFR 820 or ISO13485 headings. The principles of quality management and quality systems and quality management in both production and GMP environment will be discussed. The following quality management principles and concepts will be introduced; statistical process control; the measurement and benchmarking of quality; tools and techniques for quality improvement; organisational and teamwork requirements for quality implementation; strategic issues in quality management and finally current developments in quality management.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Non conformance reports Continuous Assessment Written Report 20 % Week 3 5,6
2 Quality Improvement Case Study Continuous Assessment Essay 30 % Week 6 2,3,4,5,6
3 MCQ/LAQ Continuous Assessment Multiple Choice 20 % Week 10 1,2,3,4
4 Document control and SOPS Continuous Assessment Written Report 20 % Week 8 2,3,4
5 Good docn practice review Continuous Assessment Assignment 10 % Week 13 2,3,4,7

Online Learning Mode Workload


Type Location Description Hours Frequency Avg Workload
Online Lecture Online Lecture 2 Weekly 2.00
Independent Learning Online Self directed learning 5 Weekly 5.00
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2016 Quality Management for Organizational Excellence Pearson

Recommended Reading
2015-04-23 Quality Management for Organizational Excellence: Introduction to Total Quality Pearson

This is the eBook of the printed book and may not include any media, website access codes, or print supplements that may come packaged with the bound book.

For courses in quality management, quality engineering, quality technology, and continuous process improvement in universities, colleges, community colleges, and corporate environments

 

A comprehensive, practical look at how to become an effective quality manager and decision maker focused on improving the quality of people, processes, products, and the work environment on a continual basis

Current and future quality managers and decision makers gain the knowledge and skills they need to achieve organizational excellence. With a focus on continually developing the quality of people, processes, products, and the work environment, it covers all pertinent quality-related topics, including: an overview of quality, quality and global competitiveness, strategic alliances, establishing a culture of quality, customer satisfaction and quality, employee empowerment, leadership and change management, team building and teamwork, education and training for quality, overcoming internal politics and conflict, quality tools, problem solving and decision making, quality function deployment, statistical process control, continual improvement methods, such as six sigma, lean, and lean six sigma), benchmarking, just-in-time/lean manufacturing, and implementing quality. The new edition features an improved artwork package; updated critical-thinking activities; and new material on managing quality in the supply chain, change to ISO 9000-2015, Lean, and Lean Six Sigma, QFD, SPC.

Module Resources

Non ISBN Literary Resources

as per book list

URL Resources

Website: https://www.accessdata.fda.gov/scripts/c drh/cfdocs/cfCFR/CFRSearch.cfm

Website: https://www.iso.org/standard/36786.html

Other Resources

as per URLs